Cannabis Impairment Detection Device Study

NCT ID: NCT07122349

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-08

Study Completion Date

2022-10-24

Brief Summary

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The goal of this study is to develop a cannabis impairment detection device in adult cannabis users. The main question\[s\] it aims to answer are:

* Is the investigational device accurate and reliable at detecting cannabis impairment?
* is the device safe for the collection of eye movement data from cannabis intoxicated individuals? Participants will be administered a series of Drug Recognition Expert Ocular Tests via the Gaize headset following cannabis consumption.

Detailed Description

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Conditions

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Cannabis Intoxication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Gaize Device

Group Type EXPERIMENTAL

Cannabis Impairment Test

Intervention Type DEVICE

Automated Drug Recognition Expert Ocular Tests administered via VR Headset, includes test for Lack of Smooth Pursuit, Horizontal and Vertical Gaze Nystagmus, Lack of Convergence, and Pupillary Rebound Dilation. Tests are preceded by an automated system calibration process.

Interventions

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Cannabis Impairment Test

Automated Drug Recognition Expert Ocular Tests administered via VR Headset, includes test for Lack of Smooth Pursuit, Horizontal and Vertical Gaze Nystagmus, Lack of Convergence, and Pupillary Rebound Dilation. Tests are preceded by an automated system calibration process.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults 19, years or older, having given written informed consent to participate in the research trial and certifying that they will not drive for a period of at least 6 hours post discharge.
* Having used cannabis at least one time prior
* Having access to legal cannabis
* Normal or corrected to normal vision using either glasses or contact lenses, or surgery.

Exclusion Criteria

* Enrolled in, or participated in another clinical trial within 30 days before the study
* Having a prosthetic eye
* Blood pressure greater than 160/90 mmHg and heart rate greater than 100 bpm.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dicentra Inc.

INDUSTRY

Sponsor Role collaborator

Gaize

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ken Fichtler

Role: STUDY_CHAIR

Gaize

Locations

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Dicentra

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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22-GPHCV-01

Identifier Type: -

Identifier Source: org_study_id

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